Combined Use of BCG and Interferon Alpha in Bladder Cancer

Carcinoma of Urinary Bladder, Superficial Clinical Trial

Official title:

A Multi-centre Randomised Controlled Double-blinded Trial of BCG and Interferon Alpha in High Risk Superficial Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330707
• Other study ID #: NMRC/0085/1995
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 26, 2006
• Last updated: March 2, 2011
• Start date: October 1995
• Est. completion date: June 2005

Study information

• Verified date: March 2011
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

To compare the toxicity and efficacy of the combination of BCG and interferon alpha to standard dose and low dose BCG alone in high risk superficial bladder cancer

Description:

140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose BCG, low dose BCG or the combination of low dose BCG and interferon alpha in a schedule of "6+3" weekly intravesical instillations. Patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. Pre-and post-instillation urine samples would be collected for cytokine analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

(1) Patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage Ta or Tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. Central pathology review was mandatory. (2) Patients with Stage Ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) Tumor recurrence during the 56 weeks prior to registration, (b) Two or more initial tumors within 28 weeks, (c) Grade III urothelial carcinoma during the 16 weeks prior to registration, (d) Dysplasia or carcinoma-in-situ on random biopsy or (e) Positive urinary cytology post tumor resection. "Suspicious" or "suggestive" cytology is insufficient for this criterion. (3) Patients who have received prior intravesical therapy other than BCG were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) There was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) Patients had a Karnofsky score >50. (6) Women of child?bearing age were using effective contraceptive methods. (7) Patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) Pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) All patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

• (1) Patients with medical illness or mental status, which would preclude cooperation with the study. (2) Patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) Patients with urothelial carcinoma of stage T2 or higher. (4) Patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) Patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) Patients who had been previously treated with intravesical BCG. (7) Patients with active tuberculosis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma of Urinary Bladder, Superficial
• Urinary Bladder Neoplasms

Intervention

Drug:
• Bacillus Calmette Guerin and interferon alpha

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local toxicity
Primary	systemic toxicity
Primary	recurrence rate
Primary	progression rate
Primary	disease-specific mortality